Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
8 september 2016 uppdaterad av: Mallinckrodt
Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery
This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.
Studietyp
Interventionell
Inskrivning (Faktisk)
331
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35249
- University of Alabama (Anesthesiology)
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Sheffield, Alabama, Förenta staterna, 35660
- Helen Keller Hospital
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Arizona
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Phoenix, Arizona, Förenta staterna, 85032
- Precision Trials
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Phoenix, Arizona, Förenta staterna, 85023
- Arizona Research Center, Inc (JC Lincoln)
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Phoenix, Arizona, Förenta staterna, 85023
- Arizona Research Center, Inc. (Arrowhead)
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California
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Arcadia, California, Förenta staterna, 91007
- Arcadia Methodist Hospital
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Glendale, California, Förenta staterna, 91206
- Glendale Adventist Medical Center
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Pasadena, California, Förenta staterna, 91105
- Huntington Memorial Hospital
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San Clemente, California, Förenta staterna, 92672
- Accurate Clinical Trials, Inc.
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Florida
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Boynton Beach, Florida, Förenta staterna, 33414
- Visions Clinical Research
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Fort Pierce, Florida, Förenta staterna, 34950
- G and G Research, Inc.
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Holly Hill, Florida, Förenta staterna, 32117
- Century Clinical Research, Inc
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Inverness, Florida, Förenta staterna, 34452
- Nature Coast Clinical Research
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Miami, Florida, Förenta staterna, 33136
- University of Miami School of Medicine Dept. of Anesthesiology
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Vero Beach, Florida, Förenta staterna, 32960
- Treasure Coast Obstetrics and Gynecology
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Michigan
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Royal Oak, Michigan, Förenta staterna, 48073
- William Beaumont Hospital
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New Jersey
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Camden, New Jersey, Förenta staterna, 08103
- Cooper Anesthesia
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New Brunswick, New Jersey, Förenta staterna, 08901
- St. Peters University Hospital, Anesthesiology
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New York
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Albany, New York, Förenta staterna, 11208
- Albany Medical College Dept. of Anesthesiology
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Bronx, New York, Förenta staterna, 10461
- Jacobi Medical Center (Albert Einstein College of Medicine)
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New York, New York, Förenta staterna, 10021
- Weill Medical College
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Stony Brook, New York, Förenta staterna, 11794
- Stony Brook Anesthesiology Health Sciences Cente
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Ohio
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Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University Medical Center
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Pennsylvania
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Altoona, Pennsylvania, Förenta staterna, 16602
- Allegheny Pain Managment
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Dept. of Anesthesiology
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Texas
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Houston, Texas, Förenta staterna, 77024
- Memorial Herman/Memorial City Hospital
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Houston, Texas, Förenta staterna, 77024
- Texas Woman's Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
- 18-75 years of age
- Body Mass Index (BMI) between 19-45
- American Society of Anesthesiologists (ASA) risk class of I, II, III
- Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
- Moderate to Severe pain at rest
Exclusion Criteria:
- Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
- Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
- Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
- Known history of alcohol or drug abuse or misuse
- Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
- Has significant medical disease(s), or conditions that may contraindicate participation in the study
- Has participated in another clinical trial within 30 days of surgery
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: IV acetaminophen 1 g/100 mL solution
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Intravenous acetaminophen 1 g/100 mL
Andra namn:
|
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Placebo-jämförare: IV Placebo 100 mL solution
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IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
Tidsram: Baseline (just prior to the first dose) through 24 hours
|
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours.
SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment.
Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable".
The range of measurement is 0-2400 mm for 24 hours.
|
Baseline (just prior to the first dose) through 24 hours
|
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Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
Tidsram: Baseline (just prior to the first dose) through 48 hours
|
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours.
SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment.
Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable".
The range of measurement is 0-4800 mm for 48 hours.
|
Baseline (just prior to the first dose) through 48 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Tidsram: First dose through 7 day follow up
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Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)
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First dose through 7 day follow up
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Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
Tidsram: 32 days following first dose of study medication.
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Number of subjects who reported SAEs during the study. A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that: Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event |
32 days following first dose of study medication.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2006
Primärt slutförande (Faktisk)
1 september 2007
Avslutad studie (Faktisk)
1 september 2007
Studieregistreringsdatum
Först inskickad
14 november 2006
Först inskickad som uppfyllde QC-kriterierna
14 november 2006
Första postat (Uppskatta)
15 november 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 oktober 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2016
Senast verifierad
1 september 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CPI-APA-301
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .